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Name:Advanced Eye Relief/ Redness Maximum Relief
Manufacturer:Bausch & Lomb Incorporated
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ADVANCED EYE RELIEF/ REDNESS MAXIMUM RELIEF - naphazoline hydrochloride and hypromellose solution/ drops 
Bausch & Lomb Incorporated

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Hypromellose (0.5%)

Naphazoline hydrochloride (0.03%)

Purpose

Lubricant

Redness reliever

Uses

  • temporary relief of redness and discomfort due to:
    • minor eye irritations
    • exposure to wind or sun
    • dryness of the eye
  • prevents further irritation

Warnings

Do not use

  • if solution changes color or becomes cloudy

Ask a doctor before use if you have

  • narrow angle glaucoma

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • do not overuse as it may produce increased redness of the eye
  • pupils may become enlarged temporarily
  • remove contact lenses before using
  • replace cap after use

Stop use and ask a doctor if

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours

Keepout of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • instill 1 to 2 drops in the affected eye(s) up to four times daily

Other information

  • store at 15°-25°C (59°-77°F)
  • keep tightly closed
  • use before expiration date marked on the carton and bottle

Inactive ingredients

benzalkonium chloride (0.01%), boric acid, edetate disodium, purified water, sodium borate, sodium chloride. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

Questions or Comments?

Toll Free Product Information or to Report a Serious Side Effect Associated with use of this product Call: 1-800-553-5340

Package/Label Principal Display Panel

Bausch & Lomb AER Redness carton

Bausch & Lomb

Advanced Eye Relief™

Redness

Maxium Relief

Redness Reliever/Lubricant Eye Drops

Relieves dry, burning and irritated eyes

Long lasting comfort

0.5 FL OZ (15mL)


ADVANCED EYE RELIEF/ REDNESS MAXIMUM RELIEF 
naphazoline hydrochloride and hypromellose solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24208-450
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 5 mg  in 1 mL
HYPROMELLOSE (HYPROMELLOSE) HYPROMELLOSE 0.3 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
BORATE ION  
SODIUM BORATE  
SODIUM CHLORIDE  
WATER  
EDETATE DISODIUM  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24208-450-15 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-450-15)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 09/02/2010

Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 114406598 MANUFACTURE

Revised: 09/2010 Bausch & Lomb Incorporated



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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